Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT) stock gained by 10.7% at last close while the ARCT stock rises by 7.53% in the pre-market trading session. Arcturus Therapeutics is located in San Diego, California, was founded in 2013, and is a clinical-stage mRNA medicines and vaccines firm with enabling technology.
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What’s happening in ARCT stock?
Arcturus Therapeutics recently announced that its partner Vinbiocare has obtained clearance from the Vietnam Ministry of Health for a Clinical Trial Application (CTA) to develop ARCT-154, a next-generation Arcturus vaccine that targets SARS-CoV-2 variations of concern, including the Delta form.
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Arcturus’ production partner Vinbiocare which is a subsidiary of Vingroup, Vietnam’s largest private industrial conglomerate is sponsoring and fully funding the ARCT-154 Phase 1/2/3 clinical investigation, which is a randomized, observer-blind, placebo-controlled design. The research will recruit up to 21,000 people in three stages to investigate the safety, immunogenicity, and effectiveness of the SARS-CoV-2 self-amplifying mRNA vaccine in adults 18 years and older. Safety and effectiveness are the primary objectives, with immunogenicity being assessed in a subset. The trial vaccination will be given in two doses separated by 28 days. After 6 months, individuals who received the placebo will get the active vaccination. For one year, all participants will be tracked. If the clinical study passes intermediate evaluations, the Vietnam Ministry of Health is expected to grant Emergency Use Approval (EUA) in December 2021.
Other Significant Development
Arcturus Therapeutics said today that it has reached a deal with Vinbiocare Biotechnology Joint Stock Company, a subsidiary of Vingroup Joint Stock Company, to build a manufacturing facility in Vietnam to produce Arcturus’ experimental COVID-19 vaccines for sale and usage in Vietnam.
Vinbiocare will construct a production facility in Vietnam with Arcturus’ assistance, and Arcturus will give Vinbiocare with access to patented technology and procedures for the manufacture of Arcturus’ experimental COVID-19 vaccines. Arcturus will grant Vinbiocare an exclusive right to produce the vaccines in Vietnam at a facility dedicated entirely to Vietnamese distribution. The license and knowledge transfer only apply to the production of drug products, not mRNA drug substances. The transfer of technology is in progress.
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Vinbiocare will pay a $40 million upfront payment and will cover all costs related with the technology transfer. Vinbiocare will also cover the cost of Arcturus’ mRNA medicinal ingredient as well as royalties on vaccines manufactured at the facility.
